- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03510793
Microcirculation and Anesthesia in Vascular Surgery
April 30, 2018 updated by: Abele Donati, MD, Università Politecnica delle Marche
Changes in the Sublingual Microcirculation Following Aortic Surgery Under Balanced or Total Intravenous Anesthesia: a Prospective Observational Study
Ischemia/reperfusion injury following aortic cross-clamping for vascular surgery leads to systemic hemodynamic and microcirculatory perturbances.
The use of different anesthetic regimens may have an impact on tissue perfusion.
The aim of this study was to explore changes in microvascular perfusion in patients undergoing elective open abdominal aortic aneurysm repair under balanced or total intravenous anesthesia.
Prospective observational study on 40 patients scheduled for elective open infrarenal abdominal aortic aneurysm repair, who received balanced (desflurane + remifentanil, n=20) or total intravenous anesthesia (TIVA, propofol + remifentanil using target-controlled infusion, n=20) according to the clinician's decision.
A goal-directed hemodynamic management was applied in all patients.
Hemodynamics and arterial/venous blood gases were compared before anesthesia induction (baseline) and at end-surgery.
Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging.
Near infrared spectroscopy was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ischemia/reperfusion (I/R) injury is a common problem in patients undergoing aortic clamping for vascular surgery and may lead to systemic inflammation and organ dysfunction.
Increased production of pro-inflammatory molecules and oxidative stress induced by I/R are responsible for microvascular alterations similar to those observed during sepsis, which result in tissue hypoxia.
Anesthetics can affect the microcirculation.
Propofol causes vasodilation stimulating NO production and decreases microvascular density.
A final arteriolar vasodilation could involve a greater oxygen delivery and better perfusion, but a massive dose-dependent vasodilation could lead to a shunt of blood flow with reduced oxygen availability.
Volatile anesthetics cause dose-dependent vasodilation too and desflurane, unlike isoflurane and alothane, maintains myocardial, hepatic, intestinal and muscle blood flow.
This prospective observational study aims to evaluate the effects of intravenous and balanced anesthesia on sublingual and peripheral muscle microcirculation in patients undergoing elective open abdominal aortic aneurysm repair.
This study was approved by the investigator's local ethical committee of Azienda Ospedaliera Universitaria "Ospedali Riuniti" of Ancona, Italy.
A written informed consent was obtained from all patients.
Patients were eligible if they were scheduled for elective infrarenal abdominal aortic open repair with or without prosthetic aorto-aortic or aorto-bisiliac bypass under general anesthesia.
Patients received balanced (desflurane + remifentanil) or total intravenous (TIVA, propofol + remifentanil, with target-controlled infusion) anesthesia according to the attending physician's decision, resulting in two study groups.
Spectral entropy was used in monitoring anesthetic depth.
A goal-directed hemodynamic management was applied in all patients.
Hemodynamics was evaluated with Flotrac/Vigileo (Edwards Lifesciences) monitor according to routine clinical practice.
Arterial and central venous blood gases were measured according to routine clinical practice.
All measurements were collected before anesthesia induction (baseline) and at end-surgery.
Changes in sublingual microvascular flow and density were assessed with incident dark field illumination imaging (Cytocam, Braedius, Amsterdam, NL).
After gentle removal of saliva and other secretions with a gauze, the probe was applied to the sublingual region, avoiding excessive pressure.
Three sequences of 10 seconds each were recorded in 3 different mucosal areas.
Subsequently, clips were analysed offline by AVA software (Automated Vascular Analysis v3.0).
The following parameters were calculated for small vessels: microvascular flow index, total vessel density, perfused vessel density, percentage of perfused vessels, flow heterogeneity index.
Near infrared spectroscopy (InSpectra, Hutchinson Technology, MN, USA) was applied on the thenar eminence with a vascular occlusion test (VOT) to assess variations in the peripheral muscle tissue oxygenation and microcirculatory reactivity.
A probe was applied on the thenar eminence, and, after a 3-minute period of stabilization, tissue O2 saturation (StO2) and tissue haemoglobin index (THI) were recorded.
Then arterial inflow was arrested by inflating a sphygmomanometer cuff to 50mmHg above the systolic arterial pressure; the cuff was kept inflated until StO2 decreased to 40% and finally was released.
StO2 modifications were continuously recorded during the reperfusion phase until stabilization.
The following parameters were extrapolated: StO2 downslope, StO2 upslope, area of hyperemia.
Statistics: normality of distribution will be assessed with Kolmogorov-Smirnov test.
Data will be expressed as mean±standard deviation or median [1st-3rd quartile], as appropriate.
Two-way ANOVA with Sidack's multiple comparisons test or Wilcoxon and Mann-Whitney U test were used to compare variables between the two time points into the same group and between two groups at time-matched points as appropriate.
A p value <0.05 was used to indicate statistical significance.
Study Type
Observational
Enrollment (Actual)
40
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
adult (>18 years old) patients scheduled for elective open aortic aneurysm repair under general anesthesia, who will receive balanced or total intravenous anesthesia according to the attending physician's decision
Description
Inclusion Criteria:
- elective infrarenal abdominal aortic open repair
- protocol of intraoperative goal-directed therapy
- ASA class I-II-III
Exclusion Criteria:
- age of less than 18 years
- pregnancy
- Endovascular Aneurysm Repair (EVAR)
- concomitant infections
- trauma
- emergency surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Balanced anesthesia
Patients receiving balanced anesthesia (desflurane + remifentanil) according to the attending physician's decision
|
patients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia
|
Total intravenous anesthesia
Patients receiving total intravenous anesthesia (TIVA) using propofol + remifentanil with target-controlled infusion according to the attending physician's decision.
|
patients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in the microvascular flow index
Time Frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Variation in the microvascular flow index, which is a parameter of capillary blood flow quality, calculated for small (diameter <20 microns) vessels in the sublingual microcirculation
|
from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in microvascular density
Time Frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Variation in parameters of sublingual total and perfused vessel densities
|
from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
change in tissue oxygenation
Time Frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Variation in skeletal muscle (thenar eminence) StO2
|
from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
change in microvascular reactivity
Time Frame: from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Variation in skeletal muscle (thenar eminence) StO2 upslope, which is the slope of the reperfusion phase during the vascular occlusion test
|
from baseline (before induction of anesthesia) to end-surgery (before anesthesia suspension)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Abele Donati, Università Politecnica delle Marche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Petros AJ, Bogle RG, Pearson JD. Propofol stimulates nitric oxide release from cultured porcine aortic endothelial cells. Br J Pharmacol. 1993 May;109(1):6-7. doi: 10.1111/j.1476-5381.1993.tb13523.x.
- Koch M, De Backer D, Vincent JL, Barvais L, Hennart D, Schmartz D. Effects of propofol on human microcirculation. Br J Anaesth. 2008 Oct;101(4):473-8. doi: 10.1093/bja/aen210. Epub 2008 Jul 23.
- O'Riordan J, O'Beirne HA, Young Y, Bellamy MC. Effects of desflurane and isoflurane on splanchnic microcirculation during major surgery. Br J Anaesth. 1997 Jan;78(1):95-6. doi: 10.1093/bja/78.1.95.
- Loggi S, Mininno N, Damiani E, Marini B, Adrario E, Scorcella C, Domizi R, Carsetti A, Pantanetti S, Pagliariccio G, Carbonari L, Donati A. Changes in the sublingual microcirculation following aortic surgery under balanced or total intravenous anaesthesia: a prospective observational study. BMC Anesthesiol. 2019 Jan 5;19(1):1. doi: 10.1186/s12871-018-0673-7.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2013
Primary Completion (Actual)
November 30, 2017
Study Completion (Actual)
November 30, 2017
Study Registration Dates
First Submitted
April 24, 2018
First Submitted That Met QC Criteria
April 26, 2018
First Posted (Actual)
April 27, 2018
Study Record Updates
Last Update Posted (Actual)
May 3, 2018
Last Update Submitted That Met QC Criteria
April 30, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Vasc2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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